McInnes et al. Journal of Foot and Ankle Research 2012, 5:9
http://www.jfootankleres.com/content/5/1/9
RESEARCH
JOURNAL OF FOOT
AND ANKLE RESEARCH
Open Access
Comparison of shoe-length fit between people
with and without diabetic peripheral neuropathy:
a case–control study
Alistair D McInnes1, Farina Hashmi1, Lisa J Farndon2, Amanda Church1, Maria Haley2, Debora M Sanger2 and
Wesley Vernon2*
Abstract
Background: Amongst the many identified mechanisms leading to diabetic foot ulceration, ill-fitting footwear is
one. There is anecdotal evidence that people with diabetic peripheral neuropathy wear shoes that are too small in
order to increase the sensation of fit. The aim of this study was to determine whether people with diabetic sensory
neuropathy wear appropriate length footwear.
Methods: A case–control design was used to compare internal shoe length and foot length differences between a
group of people with diabetes and peripheral sensory neuropathy and a group of people without diabetes and no
peripheral sensory neuropathy. Shoe and foot length measurements were taken using a calibrated Internal Shoe
Size GaugeW and a Brannock DeviceW, respectively.
Results: Data was collected from 85 participants with diabetes and 118 participants without diabetes. The mean
difference between shoe and foot length was not significantly different between the two groups. However, a
significant number of participants within both groups had a shoe to foot length difference that lay outside a
previously suggested 10 to 15 mm range. From the diabetic and non-diabetic groups 82% (70/85) and 66% (78/
118), respectively had a foot to shoe length difference outside this same range.
Conclusions: This study shows that although there is no significant difference in shoe-length fit between
participants with and without neuropathy, a significant proportion of these populations wear shoes that are either
too long or too short for their foot length according to the 10 to 15 mm value used for comparison. The study has
highlighted the need for standardised approaches when considering the allowance required between foot and
internal shoe length and for the measurement and comparison of foot and shoe dimensions.
Background
Diabetic foot ulceration is associated with increased morbidity and higher mortality rates [1-3]. Jeffcoate and Harding [4] and Pecoraro et al [5] found that in more than 80%
of cases, amputation was preceded by foot ulceration. The
financial burden is considerable and Gordois et al [6]
identified that foot ulcerations and amputations cost the
UK National Health Service (NHS) £244 million in 2001.
Boulton [7] has suggested that the lifetime risk of
those with diabetes developing a foot ulcer is as high as
* Correspondence: [email protected]
2
Primary and Community Care Services, Sheffield Teaching Hospitals NHS
Foundation Trust
Full list of author information is available at the end of the article
15%. There is now substantial evidence that diabetic
neuropathy is a major aetiological factor for diabetic foot
ulceration [8]. The mechanisms leading to foot ulceration are either extrinsic (e.g. undetected trauma) or intrinsic to the foot (e.g. neuropathy contributing to foot
deformity resulting in high multidirectional pressures
during gait) [9,10]. Moulik et al [11] reported the presence of neuropathy in 61% of patients presenting to a
foot clinic for the first time with a foot ulcer.
Other identified factors that contribute to foot ulcer
risk include body weight and footwear [12]. Footwear
has been shown to be a major contributing factor not
only in the development of foot ulceration but also subsequent amputation [13-16]. One descriptive study
reported that approximately half of the participants with
© 2012 McInnes et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
McInnes et al. Journal of Foot and Ankle Research 2012, 5:9
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diabetes and peripheral sensory neuropathy had a
footwear-related event that led to limb amputation [17].
There is much anecdotal evidence that people with diabetic neuropathy often wear shoes that are too small in
order to increase the sensation of fit [18]. Litzelman
demonstrated that diabetic patients with insensate feet
tend to buy and wear overly tight shoes, and at least 25%
of people with Type 2 diabetes wear inappropriately sized
footwear [15]. Published footwear studies of participants
with diabetes use variable criteria to measure both the foot
and the shoe and also to describe inappropriately fitting
footwear [15,19-22]. There is no unified opinion regarding
what the appropriate ‘gap’ between the distal point of the
foot and the shoe should be in order for it to be considered an appropriate fit. This ‘gap’ seems to be arbitrary in
length and dependent on various shoe manufacturers’ sizing systems. The work conducted by Chantelau and Gede
[21] provides an example of this gap being 10 to 15 mm in
order to allow "extra space for the toes when extending
during walking and standing". While a different value has
been suggested by DiMaggio and Vernon [23], their
experience-based suggestion came after completion of the
data collection phase of this study.
The aim of this study was to determine whether
people with diabetic sensory neuropathy wear appropriate length footwear compared with a control group. In
this study Chanteleau and Gede's example value of 10 to
15 mm for the difference between foot and shoe length
was used as the standard. Although Chantelau and
Gede’s suggestion was not in itself evidence-based, it has
been previously used and quoted by others, hence its
use in this study. The hypothesis tested was: participants
with diabetic peripheral neuropathy wear shorter footwear in relation to foot length compared to those without diabetes and peripheral neuropathy. This study was
intended to build on the suggestions of others and provide more useful evidence for those involved in the care
of the diabetic foot.
Methods
Study design
A case–control design was implemented to compare the
shoe-length fitting differences between two groups: (i)
individuals who had both diabetes and peripheral sensory neuropathy, and (ii) individuals who did not have
diabetes or peripheral sensory neuropathy. Ethical committee and research governance approval was sought
and granted before the study commenced. All participants gave written informed consent before entering the
study. The investigators responsible for recruitment and
data collection were provided with common training
regarding the measurement equipment used. Ethical approval was given by North Staffordshire Research and
Ethics Committee (Reference 06/Q2604/162).
Page 2 of 8
Study sample and recruitment
There is little published data concerning the relationship
between foot and shoe size in people with diabetes and
peripheral neuropathy. Harrison et al [22] considered
foot length amongst other factors, however the measurements were all taken with participants in a standing position and major differences were found in relation to
width measurements. In addition, it is not clear what, if
any, allowances were made by the authors in comparing
foot versus shoe length. It is also possible that the
authors relied solely on the manufacturers (variable) stated length for footwear. Because of the lack of data in
this area, a sample size calculation was not performed to
ascertain the minimum number of participants required
to detect clinically meaningful findings using statistical
analysis.
In the absence of a sample size calculation, recruitment figures were initially estimated using existing audit
data from one of the research sites (the Leaf Hospital,
Eastbourne, UK). The response rate for research participation by the patients at this hospital is known to be 40
to 60%. Therefore, it was anticipated that 400 patients
with diabetes would be invited to take part, which would
translate to 160 and 240 people responding (according
to the figures quoted above). Prior to the study commencing, it was envisaged that a similar number of participants for the comparison group would also be
recruited. However, under recruitment was experienced
due to time restrictions.
Patients with diabetes who were willing to participate
in the study were recruited from the podiatry service
at the Sheffield Northern General Hospital. Approximately 70% of patients attending this service were ineligible for participation as they were wearing footwear
prescribed by the hospital orthotist (see exclusion criteria below). The non-diabetic participants were
recruited from clinics at the Leaf Hospital, Eastbourne,
UK. The same recruitment procedures were employed
at both study sites where strict adherence to protocol
was maintained.
Participants were eligible if they had Types 1 or 2 diabetes (with peripheral sensory neuropathy) or were
healthy and did not have diabetes (with no sensory neuropathy) and between the ages of 40 and 75 years. Both
males and females were included in the study. Exclusion
criteria were: history of foot surgery; use of bespoke
footwear; use of more than three different pairs of shoes
in one week; use of dressings that may interfere with the
measurement of the foot (e.g. an ulcer dressing on the
first toe); rheumatoid arthritis, stroke, neurological disorders, musculoskeletal disease or major systemic
arthropathy.
All participants were asked to arrive to the clinic wearing the shoes that they most commonly wore outdoors.
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Assessment of peripheral neuropathy
All participants were assessed for the presence or absence of peripheral sensory neuropathy of both feet by
evaluating symptoms and measuring specific clinical
signs using the neuropathic symptom score [24,25], the
neuropathic disability score [26] and vibration perception threshold values [27].
The neuropathy symptom score (NSS) was used to assess the symptoms of neuropathy. An NSS score of
greater than or equal to 3 was considered abnormal (i.e.
confirmation of sensory neuropathy). The neuropathy
disability score (NDS) was used to assess for signs of
neuropathy. A score of 6 or above on the NDS [28] was
considered abnormal. Vibration perception was evaluated using a 128 Hz tuning fork at three points (plantar
aspect of the hallux, 1st and 5th metatarsal heads) on
each foot. A 10 gram monofilament was used to test for
pressure sensation at four points on each foot (hallux,
1st, 2nd and 5th metatarsal heads). An absence of the detection of pressure at one site or more indicated sensory
neuropathy. A positive outcome for each of these tests
indicated peripheral neuropathy and therefore, inclusion
or exclusion to the study depending on whether or not
the person had diabetes.
Outcome measures
The primary outcome measure was that of the difference
between the foot and shoe length for both groups. The
secondary outcome measure was the proportion of participants whose foot to shoe length difference was outside
the 10 to 15 mm range.
Foot measurements
Both feet of each participant were measured using a
Brannock DeviceW (Algeos, UK). Each participant stood
barefoot and relaxed, with the feet slightly apart and
with the weight evenly distributed between both feet.
Using the Brannock DeviceW (Figure 1) the foot being
measured was lifted and placed onto the base with the
heel being firmly located against the back of the heel
cup of the device with the researcher firmly holding the
subject’s ankle and heel cup together. The researcher
then pressed the subject's toes flat against the scale of
the device, looking vertically down on the longest toe (at
right angles) to note the foot length indicated. It is important to note that the longest toe was not necessarily
the first toe. Using a fine, non-permanent wipe-clean
marker pen and straight-edge, this position was then
marked on the device and the distance from the heel of
the device to this marked point was measured in millimetres (mm) using a calibrated ruler. The same procedure was repeated for the other foot.
Figure 1 The BrannockW device.
Footwear measurements
The subject’s footwear was placed on a firm level surface. A calibrated Internal Shoe Size GaugeW (SATRA,
UK) was then placed into the shoe and the flat bar of
the device pushed into the shoe until it clearly contacted
the end of the toe box (Figure 2). The slide of the device
was then adjusted until the rear curved bar section
touched the heel of the shoe. The internal length of the
shoe was recorded in mm. The same procedure was then
repeated for the other shoe. The measure used to test
the hypothesis was the difference between the overall
foot length and internal shoe-length.
Statistical analysis
The foot measurement was subtracted from the internal
shoe length measurement and the difference recorded in
mm. To test whether continuous data were normally distributed residual plots and the Shapiro–Wilk test were
used. Data from the diabetes group were not normally distributed, so non-parametric tests were used to confirm
significant differences between the two participant groups.
For categorical variables the Chi-square test was used and
for continuous variables that were not normally distributed the Mann–Whitney U test was used. It was decided a
priori to use the 5% two-sided significance level to decide
whether to reject the null hypothesis (p < 0.05). Statistical
analyses were carried out using SPSS 16.
Results
Outcome measurements were collected for 118 control
participants (i.e. without diabetes) and 85 people with
diabetes and peripheral neuropathy. A summary of descriptive data is provided in Table 1. The difference between internal shoe and foot size was not significantly
different between the diabetes and control groups
(p = 0.253) (Figure 3). The foot length was significantly
McInnes et al. Journal of Foot and Ankle Research 2012, 5:9
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Seventy of the 85 participants with diabetes (82%) had
a difference in foot and shoe length outside the 10 to
15 mm range. Fifteen (18%) of these participants had a
difference in foot to shoe length within the 10 to 15 mm
range. Of those outside this range, 30 of the 70 participants (43%) had a difference in foot to shoe length that
was below 10 mm (range: 0 to 9 mm) and 40 (57%) had
a difference in foot to shoe length above 15 mm (range:
16 to 37 mm). There was no statistically significant difference between the groups above and below the 10 and
15 mm range (p = 0.182).
Figure 2 The Internal Shoe Size Gauge.
greater in the group with diabetes compared to participants without diabetes (p = 0.001), as was the comparison between shoe-lengths (p = 0.001).
Seventy-eight of the 118 participants without diabetes
(66%) had a difference in foot and shoe length outside
the 10 to 15 mm range. Of those outside this range, 42
of the 78 participants (55%) had a difference in foot to
shoe length that was below 10 mm (range: -5 to 9 mm)
and 36 (47% had a difference in foot to shoe length
above 15 mm (range: 16 to 34 mm). There was a statistically significant difference in the number of participants
in each group that were within and outside the 10 to
15 mm range (p = 0.009) (Figures 4 and 5).
Discussion
This study did not find a significant difference between
the foot and internal shoe length in diabetic and nondiabetic subjects. A significant number of participants did,
however, have a gap between the toe and shoe that lay
outside Chantelau and Gede's [21] suggested 10 to 15 mm
range (p = 0.009). Therefore, according to Chantelau and
Gede, the majority of the participants (72%) in our study
were wearing footwear of incorrect length. In particular,
82% of participants with diabetes were wearing shoes of
incorrect length and 35% and 36% of the diabetic and the
non-diabetic populations respectively wore shoes that
were too short. In our study, 47% of the diabetic population and 31% of the non-diabetic population wore shoes
that were too long.
Given the fitting mismatches apparent between foot
and internal shoe-length, it is possible that participants
may have developed footwear purchasing habits before
being diagnosed with diabetes. For example, it is possible
that people had their feet measured once as an adult and
then continue to purchase the same size shoe over many
years without being re-measured, whether or not they
have been diagnosed with diabetes. It is also possible
that people do not have their feet measured at all, basing
their purchases on subjective feelings of fit adequacy
alone; a habit that would establish the perceived fit
required, and which could continue after receiving a
diagnosis of diabetes.
The foot and shoe length differences were significantly
greater in terms of overall length in the diabetic group
compared to the non-diabetic group. This could relate
Table 1 Shoe and foot length data for the diabetic and non-diabetic groups
Shoe length [mm]
Foot length [mm]
Shoe length minus foot length [mm]
Non – diabetic
(n = 118)
Diabetic
(n = 85)
Non – diabetic
(n = 118)
Diabetic
(n = 85)
Non – diabetic
(n = 118)
Diabetic
(n = 85)
Median
277
262
268
249
14
12
Maximum
302
320
290
312
34
37
Minimum
232
243
214
230
−5
0
Interquartile range
21
26
30
25
14
9
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Non – diabetic participants
Page 5 of 8
Diabetic participants
Figure 3 Comparison of the two groups and the difference in the foot and shoe lengths (p = 0.25).
to a finding by Burns et al [20] who reported that some
people purchase a larger shoe size than their foot in
order to achieve a wider width fitting, with this practice
resulting in a commensurate increase in length. In
Chantelau and Gede's study [21], the foot to shoe length
matched well with the (continental) shoe size system
used, whilst the width sizes did not, which may be another characteristic of an ill-fitting shoe.
Width measurements from a shoe fitting perspective
should, however, involve a three-dimensional assessment. Width measurement with a calliper or calliperlike device alone, such as undertaken by Chantelau and
Gede [21] and Harrison et al, [22], does not take into
consideration the depth needed to accommodate the
foot – a consideration that is closely related to the
width. As such, shoe width fitting involves a balance between the actual shoe width, foot width, foot depth and
available shoe depth and this complexity makes the
width dimension more difficult to measure. Therefore,
width fitting may be an important factor in correct shoe
fitting, but to achieve an acceptable width fitting, the
length fitting may need to be compromised.
The gap required between foot and overall internal shoe
length of 10 to 15 mm as suggested by Chantelau and
Gede is greater than others quoted in the literature (e.g.
the 8.5 mm quoted by DiMaggio and Vernon [23]). Both
values are intended to allow the foot to extend whilst
standing and walking, however these values have also been
stated within different fitting contexts. Continental shoe
sizing systems are used across mainland Europe, where
Chantelau and Gede are based, while US and UK shoe size
systems apply to the working context of DiMaggio (US)
and Vernon (UK). The US and UK systems half size availability of 4.25 mm allows a greater range of fitting choice
between sizes than the Continental system, which allows
2/3 cm (6.66 mm) between size options [29]. As such,
with fewer size options in the Continental system, there
may be no option other than to recommend a wider allowance from the distal end of the toe to the shoe in order
to allow adequate extension of the foot within the shoe.
This may explain the reason for Chanteleau and Gede's
larger value.
Alternately, it is possible that Chantelau and Gede's
value is erroneous. They refer to their 10–15 mm value
as an example of the gap between foot and shoe-length.
However, the data tables presented by Chantelau and
Gede appear to indicate gaps predominantly in the order
of 6–11 mm, with a modal value of 9 mm – a lower
range than his suggested example and more in line with
the 8.5 mm allowance.
Whichever reason accounts for the differences between Chanteleau and Gede's value and those suggested
by others, there is a need for an appropriate standardised
measurement and sizing system. Such a system should
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Non – diabetic participants
Page 6 of 8
Diabetic participants
Figure 4 Comparison of the two groups and the difference in the foot lengths (p = 0.001).
consider all relevant factors to ensure that a baseline of
agreement exists in relation to length and width measurements in the context of foot health.
One inconsistency in the literature is in the measurement of foot to internal shoe-length. The current study
used a calibrated internal shoe size gauge (mm)W
(SATRA, UK), whilst others have used the following disparate methods, a motorised measuring apparatus [21]; a
calibrated (in centimetres) measuring stick and conversion to shoe size [22]; nurse-clinician thumb size to determine end of foot to shoe gap [15]; internal calliper
measurements and shoe size [20]; and the use of English
shoe size to calibrated measuring stick [19].
In a previous descriptive study of one hundred participants with diabetes, the foot length was measured with
the use of a commercial shoe company’s measuring device
[22]. The foot length was measured both seated and standing, and the shoe length was measured in centimetres with
the use of a calibrated stick, with differences between shoe
and foot length being calculated and recorded. The
authors concluded that about 33% of patients were more
than a half size out in shoe length when seated. One particular finding was that there was no relationship between
footwear size and the presence of sensory neuropathy [22].
It is not clear from this article what allowances were made
in the study for movements such as slippage when
comparing measurements of overall foot and internal
shoe-lengths.
The criteria for ‘ill-fitting’ footwear and the methods for
measuring the foot and shoe differ widely. This compromises the determination of the prevalence of ill-fitting footwear in a diabetic population as considered in this study.
Our study has attempted to determine the relationship of
the foot length to the shoe length by taking a standardised
approach to both foot and shoe measurements and this
approach has highlighted the discrepancies and lack of
standardisation in both the measurement techniques and
allowances made in shoe fitting.
It is important to note that loose fitting shoes can also
potentially cause those pathologies that are related to
increased levels of dynamic friction forces between the
foot and shoe (e.g. blisters and callus formation), which in
the diabetic population can have more serious sequelae.
There is sufficient compelling evidence that footwear contributes to foot ulceration [14]. One study [15], investigated the role of footwear in the prevention of foot lesions
in people with type 2 diabetes and reached a controversial
conclusion that there was no interaction between neuropathy and footwear in the aetiology of foot wounds.
However, this was challenged by Chantelau and Gede [21]
who suggested that a significant number of people with
diabetic neuropathy developed shoe induced foot ulcers.
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Non – diabetic participants
Page 7 of 8
Diabetic participants
Figure 5 Comparison of the two groups and the difference in the shoe lengths (p = 0.001).
Despite the studies in this area using different methodologies and taking place within different operating contexts,
they have reached similar conclusions; a significant number
of people with and without diabetes do not wear appropriately sized shoes. However, the objective identification of
specific characteristics of a good fitting shoe remains elusive. A trained shoe fitter can identify characteristics of a
shoe that indicate poor fit, but this is very much a craft skill,
much of which is not currently supported by research
evidence.
This study needs to be viewed in light of a few limitations. Firstly, participant characteristic data, such as
height, age and weight, were not recorded, so we were unable to compare the two groups for differences in these
variables. There is the possibility that some of these variables (e.g. height) may have had an effect on foot length. If
the example of height is explored further, then the significant difference we found in foot length may have simply
been due to a difference in height between the two groups.
We were, however, primarily interested in the difference
between foot length and shoe length, not foot length
alone. Secondly, a power calculation (i.e. a sample size calculation) was not performed prior to the study commencing recruitment and the sample size estimate we did
make was not reached. This may have affected whether we
had sufficient statistical power to detect clinically worthwhile differences between shoe length and foot length.
Finally, it was not anticipated that the majority of participants with diabetes and neuropathy would already have
bespoke footwear, which resulted in lower numbers of eligible patients being able to enter the study. Further research in this area should consider a longer recruitment
time and include more than one centre to ensure that
enough participants are able to take part.
Conclusion
In our study we did not find a significant difference between the foot to internal shoe length relationship of a
diabetic and non-diabetic group of adult participants.
However, from a clinical perspective, those patients who
may be considered at risk of diabetic foot complications
can be considered to be wearing footwear that is frequently too short or too long. Further research is
required to establish valid criteria for good-fitting footwear; standardise the approach to measure foot and shoe
parameters of length, depth and width, and standardise
the required gap between the foot and shoe length in
order to determine ideal shoe-length. It is possible that
certain characteristics of footwear design may interact
with the vulnerable foot (i.e. one that has neuropathy) as
opposed to characteristics that are inherently ‘ill-fitting’.
In addition to this, further work to test and validate the
craft knowledge of the shoe fitter is pertinent. Whilst
the role of the effects of therapeutic footwear has been
McInnes et al. Journal of Foot and Ankle Research 2012, 5:9
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evaluated [30] and the effect of footwear as a contributing factor in the pathway to diabetic foot ulceration has
been identified [14], the lack of standardisation of footwear measurement prevents recording of the true prevalence of ill-fitting footwear in the diabetic population.
Declaration of competing interests
The authors declare that they have no competing interests.
Acknowledgements
The authors would like to thank Dr Elizabeth Cheek and Professor Jackie
Campbell for their advice regarding statistical analysis and all the people
who participated in the trial. This work was supported by a Short Term
Project Grant from the Sheffield Health and Social Research Consortium, UK.
Author details
1
Division of Podiatry, School of Health Professions, University of
BrightonBrighton, UK. 2Primary and Community Care Services, Sheffield
Teaching Hospitals NHS Foundation Trust.
Authors’ contributions
AC participated in the recruitment of volunteers for the study and data
collection. LF participated in the co-ordination of the study; interpretation of
data and revising the manuscript. FH participated in the design and coordination of the study, performed the statistical analysis, and contributed to
drafting the manuscript. AM conceived and participated in the design of the
study. WV conceived and participated in the design of the study. DS
participated in the recruitment of participants for the study and data
collection. MH participated in the recruitment of participants for the study
and data collection. All authors read and approved the final manuscript.
Received: 26 July 2011 Accepted: 16 April 2012
Published: 16 April 2012
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doi:10.1186/1757-1146-5-9
Cite this article as: McInnes et al.: Comparison of shoe-length fit
between people with and without diabetic peripheral neuropathy: a
case–control study. Journal of Foot and Ankle Research 2012 5:9.
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